Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K112193
ARROW REVERSE SHOULDER SYSTEM · Fournitures Hospitalieres Industrie · decided 2012-07-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ARROW® | 265143 - STD HUMERAL INSERT, Ø36 / H10 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651434 |
| ARROW® | 265165 - CANCELLOUS BONE SCREW, Ø5,5 L40 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651656 |
| ARROW® | 265146 - STD HUMERAL INSERT, Ø39 / H10 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651465 |
| ARROW® | 265153 - CEMENTLESS METAL-BACK GLENOID BASE, S44 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651533 |
| ARROW® | 265142 - STD HUMERAL INSERT, Ø36 / H05 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651427 |
| ARROW® | 265162 - CANCELLOUS BONE SCREW, Ø5,5 L34 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651625 |
| ARROW® | 265145 - STD HUMERAL INSERT, Ø39 / H05 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651458 |
| ARROW® | 265154 - CEMENTLESS METAL-BACK GLENOID BASE, S46 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651540 |
| ARROW® | 265171 - CORTICAL BONE SCREW, Ø4,5 L38 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651717 |
| ARROW® | 265168 - CORTICAL BONE SCREW, Ø4,5 L32 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651687 |
| ARROW® | 265151 - CoCr GLENOSPHERE, Ø39 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651519 |
| ARROW® | 265148 - STD HUMERAL INSERT, Ø42 / H05 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651489 |
| ARROW® | 265155 - CEMENTLESS METAL-BACK GLENOID BASE, S48 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651557 |
| ARROW® | 265167 - CANCELLOUS BONE SCREW, Ø5,5 L50 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651670 |
| ARROW® | 265150 - CoCr GLENOSPHERE, Ø36 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651502 |
| ARROW® | 265152 - CoCr GLENOSPHERE, Ø42 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651526 |
| ARROW® | 265141 - STD HUMERAL INSERT, Ø36 / H00 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651410 |
| ARROW® | 265144 - STD HUMERAL INSERT, Ø39 / H00 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651441 |
| ARROW® | 265164 - CANCELLOUS BONE SCREW, Ø5,5 L38 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651649 |
| ARROW® | 265161 - CANCELLOUS BONE SCREW, Ø5,5 L32 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651618 |
| ARROW® | 265149 - STD HUMERAL INSERT, Ø42 / H10 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651496 |
| ARROW® | 265169 - CORTICAL BONE SCREW, Ø4,5 L34 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651694 |
| ARROW® | 265163 - CANCELLOUS BONE SCREW, Ø5,5 L36 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651632 |
| ARROW® | 265166 - CANCELLOUS BONE SCREW, Ø5,5 L45 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651663 |
| ARROW® | 265172 - CORTICAL BONE SCREW, Ø4,5 L40 | FOURNITURES HOSPITALIERES INDUSTRIE | KWS KWT | 03661489651724 |